Clinical trial Recruiting at 1 site Observational Ages 18 and up

MiRNA markers in septic shock patients

Official title: MIRSEP - MIRNA QUANTIFICATION IN PATIENTS WITH SEPTIC SHOCK

Run by Insel Gruppe AG, University Hospital Bern · NCT07597122 · Data updated 2026-11-12

This study tests whether microRNA patterns can help explain changes in immune marker HLA-DR on monocytes in adults with septic shock.

Quick facts

Study typeObservational
Ages18 Years and up
SexAll
Enrollment56 (estimated)
SponsorInsel Gruppe AG, University Hospital Bern
Academic / other
Drugs / interventionsrituximab, prednisone
Locations1 site (Bern)
StatusRecruiting
StartedJune 1, 2026
Main results expectedMay 31, 2027
Study endsDecember 31, 2027
Registry record updatedJune 2, 2026
Trial IDNCT07597122 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Adults (18+) with new-onset septic shock or critical illness on mechanical ventilation in the ICU, able to consent via independent physician, and meeting duration and language criteria.

Probably not a fit

Patients who do not exhibit relevant miRNA-HLA-DR associations or who have conditions outside Sepsis-3 criteria may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study investigates early microRNA changes and their association with HLA-DR expression on circulating monocytes in patients with septic shock. The aim is to improve understanding of sepsis-induced immunosuppression and its link to secondary infections and mortality. Data are collected from adults meeting Sepsis-3 criteria and requiring vasopressors, with samples taken early after septic shock onset. The study is conducted at Inselspital in Bern, led by Insel Gruppe AG/University Hospital Bern, and does not specify an intervention.

Why it matters

Potential benefit: If successful, findings could clarify mechanisms of immunosuppression in septic shock and inform future biomarker-guided strategies.

How similar studies have gone: Previous research has linked HLA-DR downregulation on monocytes to sepsis outcomes; this study explores a novel miRNA-mechanism angle in a similar patient population.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

Septic shock:

* New onset (\<24h) of septic shock diagnosis according to Sepsis-3 definition
* (suspected) infection
* Vasopressors required to maintain mean arterial pressure ≥65mm Hg (despite adequate fluid resuscitation)
* Serum lactate level \> 2mmol/L
* Minimum age of 18 years
* Expected length of stay \>48h
* Written consent from an independent physician

Critically ill:

* Patients on mechanical ventilation (MV) in the ICU without an admission diagnosis of sepsis/septic shock according to Sepsis-3 definition
* Minimum age of 18 years
* Expected length of stay \>48h
* Written consent from an independent physician

Exclusion Criteria:

* Age \< 18 years
* Patients known not to speak German or French
* Patients with known.

  1. Pre-existing congenital or acquired severe immune deficiency (e.g. severe combined immunodeficiency, HIV infection, AIDS) or
  2. current immunosuppressive therapy (immunosuppressive biologicals or active lymphocyte therapy e.g. endoxan, rituximab or corticosteroid use at a dose \> 10 mg/day equivalent of prednisone. However, acute corticosteroid treatment of a relative adrenal insufficiency using a maximum hydrocortisone dose of 200 mg/day is accepted.

Where it's running

  • Inselspital
    Bern, Switzerland
    Recruiting

Similar studies

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.